Imagine getting inside the head of a working FDA inspector and receiving the same training the inspector gets, knowing which problems face the most scrutiny all before the next inspection.

FDA Compliance Boot Camp 2014 includes three courses: one based on the same computerized system validation and Part 11 training the FDA gives its own investigators, one on CAPA systems and one on risk management.

A global team of FDA compliance experts based near FDA headquarters in Washington, DC, EduQuest will present FDA Compliance Boot Camp 2014, at the Hilton Garden Inn in Frederick, Maryland. Course #1 FDA Auditing of Computerized Systems and Part 11/Annex 11 is a three-day training course that includes three hands-on, mock FDA inspections teaching agency expectations for:

In addition to providing simulated FDA audits, the class explains the FDA Part 11 regulation and the EU Annex 11 guidance for managing electronic records and ensuring data quality; clarifies FDA expectations for software development and validation, and provides lessons learned from FDA regulatory enforcement actions.

The class is designed for quality managers and those responsible for regulatory compliance, clinical data assurance, internal audits, document management, and IT engineering at pharmaceutical, medical device, biotechnology, clinical research, tobacco and food companies.

Immediately following the class, EduQuest also will offer two-day classes on CAPA and Quality Risk Management:

The CAPA Confidence Clinic: FDA Rules for CAPA Systems, Failure Investigations and Complaint Management — This course offers instruction on the identification of corrections, corrective actions and preventive actions along with terms that are used to describe nonconformities and CAPA data sources.

Quality Risk Management for FDA/ICHQ9 Compliance: Agency Expectations, Global Standards and Tools for Success — Risk management is the bedrock of FDA regulation in the 21st Century. Companies that ignore the heightened public and legal demand for cradle-to-grave product risk management imperil their shareholders and their public reputation. Train your key staff on the biggest compliance pitfalls facing companies today.

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About EduQuest
Since its founding in 1995, EduQuest has trained staff in the FDA Office of Regulatory Affairs (ORA), which is responsible for FDA field inspections and product recalls. In addition, EduQuest has trained and advised industry professionals worldwide. Martin Browning, the president of EduQuest and primary developer of EduQuest training classes, co-wrote the FDA Part 11 rule for electronic records and electronic signatures during his 22 years at FDA.